The Roche booth will feature technology designed to help diagnostic laboratories do more with less and enhance the medical value they offer to clinicians and their patients. Specific product areas will include integrated clinical chemistry and immunoassay analyzers, automated molecular diagnostics platforms, pre- and post-analytical automation components, information technology solutions, and chemistry, immunoassay, molecular and tissue diagnostics tests.

New products that will be featured in the booth include:

cobas b 123 POC systemmobile blood gas analyzer for hospital POC

A mobile blood gas analyzer designed for hospital point-of-care settings, the cobas b 123 POC system offers next-generation technology that helps ensure reliable performance by virtually eliminating the introduction of blood clots that can contribute to analyzer downtime and negatively impact patient care. The analyzer features an unparalleled four-level clot protection system that helps prevent clots that can lead to reagent pack failuresa major issue for healthcare facilities because replacing the pack takes time away from patient care and wastes usable reagent. The cobas b 123 POC system also offers automatic linearity testing and calibration to simplify both workflow and regulatory compliance.

cobas p 312 pre-analytical systemsample management on small footprint

This front-end automation solution offers comprehensive, vendor-neutral sample management for labs with limited floor space. The compact, stand-alone system performs sample registration, sorting, decapping and archiving of all sample tubesincluding chemistry, immunoassay, hematology, coagulation and urinalysisfor the entire laboratory, including non-Roche equipment. With a very small footprint and throughput of up to 450 tubes per hour, the system is ideal for customers who are looking for an entry-level step into automation for pre-analytical workflow.

These stand-alone, fully automated systems are designed to accommodate the needs of mid- to high-volume customers using state-of-the-art technology to create custom sample handling solutions that help improve workflow. Both provide centrifugation, registration, sorting, decapping, recapping and archiving of sample tubes for serum work area, hematology, coagulation and urinalysis. The cobas p 612 system runs up to 655 primary tubes per hour and also provides aliquoting. The cobas p 512 system runs up to 1,000 primary tubes per hour and features a smaller footprint.

This pre-analytical instrument unites primary tube handling with fully automated sample preparation, amplification and detection for molecular diagnostics on COBAS® AmpliPrep instruments and COBAS® TaqMan® analyzers. The up-front automation solution helps labs enhance their throughput for a broad menu of important molecular virology tests, including HIV, hepatitis B and hepatitis C. The cobas p 630 Instrument is designed to protect the integrity of the primary patient tube and combines automated primary tube handling with full sample traceability, process surveillance and bi-directional connectivity. Together, these features help labs improve efficiency by effectively eliminating manual steps.

cobas CT/NG Testscreening for chlamydia and gonorrhea infection

A polymerase chain reaction (PCR)-based multiplex dual probe assay, this molecular test is used to screen and diagnose chlamydiaand gonorrhea infection in symptomatic and asymptomatic patients. It runs on the automated cobas 4800 system and offers excellent sensitivity and high specificity. The test uses male urine and self-collected vaginal swabs, which are the preferred specimen types according to the CDC. They show high sensitivity yet are less invasive and less painful to collect than urethral or endocervical samples and thus may help promote screening compliance.

The first FDA-approved laboratory test for quantifying DNA of the potentially deadly cytomegalovirus (CMV), Roche's new real-time PCR-based CMV test is intended for use as an aid in the management of solid-organ transplant patients who are undergoing anti-CMV therapy. Physicians use viral load information from the test to help manage patients who have been diagnosed with CMV disease, specifically patients whose immune system has been suppressed for solid organ transplantation. The test uses human plasma specimens and runs on the fully automated COBAS® AmpliPrep/COBAS® TaqMan® System, an established platform for viral load monitoring of multiple infectious diseases.

Dual-target HIV viral load test with manual specimen preparation

The COBAS® TaqMan® HIV-1 Test, v2.0 utilizes the FDA-approved High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. Based on Roche's innovative dual-target approach, this viral load test targets two highly conserved regions of the HIV-1 genome and avoids any regions which are current drug targets, thus providing increased reliability as compared to other single target assays should a mutation occur.

Elecsys® Vitamin D assay (25-hydroxyvitamin D)*

An electrochemiluminescence (ECL) assay designed to detect vitamin D sufficiency utilizing both serum and plasma samples, this fully automated, total vitamin D assay (25-hydroxyvitamin) can be combined with routine testing on existing Roche immunoassay analyzers and integrated chemistry/immunoassay systems, enabling labs to address the growing demand for vitamin D testing while maximizing their productivity. The assay is designed for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments, including the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602 and MODULAR ANALYTICSE 170 analyzers.

*As of July 16, this product is not yet available in the U.S. A 510(k) submission is pending.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com or www.roche-diagnostics.us.

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